acute bronchitis
Conditions
Interventions
Group 1:20mg Alstonia scholaris leaf alkaloid capsule (ASLAC)
Group 2:40mg Alstonia scholaris leaf alkaloid capsule (ASLAC)
Group 3:80mg Alstonia scholaris leaf alkaloid capsule (ASLAC)
Sponsors
Xiyuan Hospital, CACMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. subjects whos meet the diagnosis of acute bronchitis; 2. aged between 18-65,male and female; 3. course of disease within 48h; 4. BSS above 5 scores; 5. Subject who can understand and follow the study process and restrictions, volunteer to participate in the study and provide written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. The upper limit of leucocyte exceeds 11 * 10^9/L or the neutrophil exceeds 80%; 2. Subjects with chronic obstructive pulmonary disease, cardiovascular disease, nervous system disease, diabetes, recent viral infection and immune deficiency; 3. Abnormal liver function (>2ULN) or renal function; 4. Severe hypersensitivity, or at least 2 drug allergies; 5. Women during lactation or gestation or male or female subjects who have fertility requirements (including men) or who are unable to carry out safe and effective contraceptive measures within 3 months of the plan; 6. Those who have participated in other clinical trials within 3 months prior to screening; 7. Those who cannot take medicine as prescribed by the doctor; 8. Subjects considered by the researcher to be unsuitable for other conditions in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough disappearance time;Cough symptom score;Visual simulation score;Bronchitis severity score;Pharmacokinetic indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Eotaxin;IgE;SOD;IL-4;IL-10;HMOX1;PDE4B;PDE4D;ALB;vital sign;physical examination;liver function;renal function;MDA; | — |
Countries
China
Contacts
Public ContactLi Rui
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed